LCS UNI TOTAL KNEE SYSTEM
FDA premarket approval P910016/S012 · decided 2002-02-04
Approval details
- PMA number
- P910016
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LCS UNI TOTAL KNEE SYSTEM
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Applicant
- Depuy, Inc.
- Date received
- 2001-12-12
- Decision date
- 2002-02-04
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- MBD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE TIBIAL TRAY AND TIBIAL BEARING COMPONENTS OF THE LCS UNI TOTAL KNEE SYSTEM. THESE MODIFICATIONS INCLUDE: A CHANGE TO THE PROXIMAL ARTICULATING SURFACE OF THE TIBIAL BEARING IN ORDER TO ACCOMMODATE IT'S USE WITH THE PRESERVATION UNI FEMORAL COMPONENT; A CHANGE IN POLYETHYLENE RAW MATERIAL; A 1 MM REDUCTION IN THE DOVETAIL HEIGHT OF THE POLYETHYLENE BEARING; REFINING THE OUTER PROFILE OF THE TIBIAL TRAY TO BE LEFT/RIGHT SPECIFIC AND TO OPTIMIZE THE TI
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PINNACLE CONSTRAINED ACETABULAR LINERS (K043058) | Depuy, Inc. | 2005-03-14 |
| LPS UPPER EXTREMITY (K042664) | Depuy, Inc. | 2004-12-08 |
| LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (K041085) | Depuy, Inc. | 2004-07-22 |
| LPS (K033959) | Depuy, Inc. | 2004-07-01 |
| DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 (K040544) | Depuy, Inc. | 2004-05-28 |
| DELTA SHOULDER (K021478) | Depuy, Inc. | 2003-11-18 |
| DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (K033329) | Depuy, Inc. | 2003-11-14 |
| DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (K032151) | Depuy, Inc. | 2003-09-26 |